Wrist Arthroscopy Study

Wrist Arthropathy Clinical Trial

Official title:

A Comparative Study Evaluating the Diagnostic Accuracy of Wrist Arthroscopy Using the NanoScope Compared to Conventional Arthroscopic Instrumentation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04457362
• Other study ID #: 20-00356
• Status: Completed
• Phase: N/A
• Start date: October 10, 2020
• Est. completion date: March 22, 2023

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the diagnostic efficacy of Arthrex NanoScope compared to conventional arthroscopic instruments. Patients with wrist pathology who are indicated for an arthroscopic procedure will be enrolled pre-operatively after a thorough discussion of the study aims, risks, and benefits. At the time of surgery, under standard conditions, using standard wrist arthroscopy portals, a diagnostic arthroscopy will be performed with the Arthrex Nanoscope. The diagnostic arthroscopy will be performed in a stepwise manner for consistency with notation of pathology and intended intervention. The diagnostic arthroscopy will then be performed with the standard arthroscopic equipment, again noting pathology and final intervention. Post-operatively, diagnostic accuracy, incidence of change in intervention, and surgeon rated ease of use and confidence will be determined.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 22, 2023
• Est. primary completion date: March 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age > 18 years.

2. Wrist pathology based on clinical examination/imaging studies undergoing wrist arthroscopy for further evaluation/treatment.

3. Willingness to participate in the study

Exclusion Criteria:

• 1. Age < 18 years.

Related Conditions & MeSH terms

• Joint Diseases
• Wrist Arthropathy

Intervention

Diagnostic Test:
• Diagnostic Arthroscopy using the Arthrex NanoScope
A diagnostic arthroscopy will be performed with the Arthrex NanoScope. Structures evaluated: Radial styloid Proximal scaphoid articular cartilage Scaphoid fossa Radioscaphocapitate (RSC) ligament Long radiolunate (LRL) ligament Short radiolunate (SRL) ligament Scapholunate (SL) ligament Proximal lunate articular cartilage Lunate fossa Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make an initial diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, ligament injury and determine the intended treatment.
• Diagnostic Arthroscopy using standard arthroscopic instruments
A diagnostic arthroscopy will be performed with the standard arthroscopic instruments. Structures evaluated: Radial styloid Proximal scaphoid articular cartilage Scaphoid fossa Radioscaphocapitate (RSC) ligament Long radiolunate (LRL) ligament Short radiolunate (SRL) ligament Scapholunate (SL) ligament Proximal lunate articular cartilage Lunate fossa Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make the final diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, and ligament injury and determine the final treatment.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon-Rated Radiocarpal Visualization With Arthrex Nanoscope	Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.	Day 1
Primary	Surgeon-Rated Radiocarpal Visualization With Conventional Instrument	Radiocarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.	Day 1
Primary	Surgeon-Rated Midcarpal Visualization With Arthrex Nanoscope	Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.	Day 1
Primary	Surgeon-Rated Midcarpal Visualization With Conventional Instrument	Midcarpal visualization rated on a 5-point scale: (1) - bad; (2) - poor; (3) - fair; (4) - good; (5) - excellent.	Day 1
Secondary	Surgeon-rated Ease of Use of Arthrex NanoScope	Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.	Day 1
Secondary	Surgeon-rated Ease of Use of Conventional Instrument	Ease of use will be rated on a 5-point scale: (1) - very difficult; (2) - difficult; (3) - neutral; (4) - easy; (5) - very easy.	Day 1
Secondary	Surgeon-rated Confidence in Arthrex NanoScope Diagnosis	Confidence will be rated on a 5-point scale: (1) - not at all confident; (2) - not very confident; (3) - neutral; (4) - fairly confident; (5) - very confident.	Day 1
Secondary	Surgeon-rated Confidence in Conventional Instrument Diagnosis	Confidence will be rated on a 5-point scale: (1) - not at all confident; (2) - not very confident; (3) - neutral; (4) - fairly confident; (5) - very confident.	Day 1